Regulatory Affairs
Lifecycle monitoring of:
- Medicinal Products for Human Use
- Medicinal Products for Veterinary Use
- Medical Devices
- Cosmetics
- Food Supplements
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Quality Assurance
- Implementation and Maintenance of Quality Management Systems
- Internal Audits of Quality Management Systems
- Mock Audits
- Change Controls, Deviation Management, CAPA, Risk Management
Entity Licensing
- Manufacturers of Medicinal Products for Human and Veterinary Use
- Manufacturers of Medical Devices
- Wholesale Distributors of Medicinal Products for Human and Veterinary Use
- Wholesale Distributors of Medical Devices
- Retail Establishments of Medicinal Products for Veterinary Use
- Intermediation of Medicinal Products for Human Use
- Non-Prescription (OTC) Medicines Retailers
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Marketing and Advertising
- Regulatory support
- Elaboration, review and notification of advertising materials
- Product Marketing
- Market research
- Brands representation
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Pharmacovigilance
- Local Contact for Pharmacovigilance in Portugal
- ICSR management, including collection, evaluation, processing, distribution and reporting
- Literature monitoring
- Signal management
- Risk management
- Periodic safety reports
- Pharmacovigilance system and compliance
- Quality system, audit and inspection support
- Training
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Partners
